Dibucaine
- Product NDC
- 69396-023
- 11-digit product format
- 693960023
- Labeler code
- 69396
- Product ID
- 69396-023_0df7b6dd-a4d8-c9a6-e063-6394a90a0f52
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dibucaine 1%
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Trifecta Pharmaceuticals USA LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-14
- Substance
- DIBUCAINE
- Active strength
- 1 g/100g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dibucaine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIBUCAINE | 1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L6JW2TJG99 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 238784 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e8a56651-a292-7609-e053-2a95a90a7c36 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69396-023-01 | Dibucaine | 28.4 g in 1 TUBE | OINTMENT | 28.4 | 2 | |
| 69396-023-01 | Dibucaine | 1 in 1 BOX | OINTMENT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| QIAN LI ZHUI FENG PAIN RELIEVING | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | MADISON ONE ACME INC | 03a4fb7c-2328-409d-99c8-cbcf2b4a451f | 2025-11-10 | Warnings, Adverse reactions | M017 |
| WU YANG BRAND PAIN RELIEVING MEDICATED | MENTHOL AND CAMPHOR | MADISON ONE ACME INC | 05c6b95a-aeb6-4234-97c7-8d77eccb38d8 | 2025-11-10 | Warnings | M017 |
| HEI GUI PAIN RELIEVING | CAMPHOR AND METHYL SALICYLATE | MADISON ONE ACME INC | 4140c404-edab-4923-941d-f74125e943a9 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| E MEI SHAN MEDICATED | CAMPHOR AND MENTHOL | MADISON ONE ACME INC | ddcc814e-fcc4-4232-9ab4-826b8aac35f0 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Overtime | METHYL SALICYLATE, MENTHOL AND CAPSAICIN | Physicians Science & Nature Inc. | 25fec070-8587-42d1-ba6f-1a9c150acc98 | 2025-11-10 | Warnings | M017 |
| Dendracin Neurodendraxcin | METHYL SALICYLATE, MENTHOL AND CAPSAICIN | Physicians Science & Nature Inc. | 05742cd5-ece2-4007-bdf0-46b76d23df74 | 2025-11-10 | Warnings | M017 |
| Anal Blu | DESENSITIZER | Novelties by Nasswalk, Inc. | 03b9555b-c3ff-4baa-e063-6394a90afb2c | 2025-11-10 | Warnings | M017 |
| Stallion | DELAY CREME | Novelties by Nasswalk, Inc. | 0261ec88-8fe4-d5f8-e063-6294a90ab3d4 | 2025-11-10 | Warnings | M017 |
| ANAL-ESE | DESENSITIZER | Novelties by Nasswalk, Inc. | 03b89eed-b433-a263-e063-6294a90a675b | 2025-11-10 | Warnings | M017 |
| Instant Erection | ULTIMATE ERECTION ENHANCER | Novelties by Nasswalk, Inc. | 03a444f9-7052-0c38-e063-6294a90a4e56 | 2025-11-10 | Warnings | M017 |
| STA-HARD | DESENSITIZING LUBRICANT | Novelties by Nasswalk, Inc. | 02ef794b-8e70-5c26-e063-6294a90a28d1 | 2025-11-10 | Warnings | M017 |
| ANAL-ESE | DESENSITIZER | Novelties by Nasswalk, Inc. | 03a4a7ce-4cff-a608-e063-6294a90ad65d | 2025-11-10 | Warnings | M017 |
| FOOTSPA PEDI | ALCOHOL | CHEMCO CORPORATION | 04de4392-74f6-7df8-e063-6294a90ae3b1 | 2025-11-08 | Warnings | M017 |
| Johnson and Johnson All Purpose First Aid Kit | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 5cdb47c5-7951-4279-8a05-0a3199d3dd45 | 2025-11-06 | Warnings | M017 |
| Johnson and Johnson First Aid Travel Ready 80 CT | ACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | f388f105-48ba-4616-e053-2a95a90a0049 | 2025-11-06 | Warnings | M017 |
| Johnson and Johnson First Aid All Purpose 160 CT | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | f3933330-2550-4a88-e053-2a95a90a3997 | 2025-11-06 | Warnings | M017 |
| Foot and Leg Pain Relief | LIDOCAINE | Premier Brands of America Inc. | 42f23e2f-11c6-da49-e063-6294a90ac720 | 2025-11-06 | Warnings | M017 |
| HEALING TREE CALMING ANTI-ITCH | HYDROCORTISONE | Renu Laboratories, LLC | fc8bcde9-26e8-a35f-e053-6394a90a3300 | 2025-11-06 | Warnings | M017 |
| Calamine Plus | CALAMINE PLUS PRAMOXINE HCL | Chain Drug Marketing Association Inc | 1a3f8819-58cf-8923-e063-6394a90a37af | 2025-11-06 | Warnings | M017 |
| Extra Strength Itch Relief | DIPHENHYDRAMINE HCL AND ZINC ACETATE | Chain Drug Marketing Association Inc | 1a2997bc-7741-e658-e063-6394a90af6fd | 2025-11-06 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238784 | dibucaine 1 % Rectal Ointment | PSN | e8a56651-a292-7609-e053-2a95a90a7c36 | 2 |
| 238784 | dibucaine 0.01 MG/MG Rectal Ointment | SCD | e8a56651-a292-7609-e053-2a95a90a7c36 | 2 |
| 238784 | dibucaine 1 % Rectal Ointment | SY | e8a56651-a292-7609-e053-2a95a90a7c36 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69396-023-01 | 69396002301 | 1 TUBE in 1 BOX (69396-023-01) / 28.4 g in 1 TUBE | 1 tube | 2022-09-14 | 0000-00-00 | No | No | Current |